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Renal Transplant clinical trials

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NCT ID: NCT03020589 Completed - Renal Transplant Clinical Trials

Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients

TAC3A5
Start date: February 6, 2017
Phase: Phase 4
Study type: Interventional

Objective: Investigate the direct correlation of CYP3A5 genotype with tacrolimus trough levels and clinical outcomes. The primary endpoint of this study is to evaluate the proportion of patients reaching target levels (8-10 ng/mL) on Day 3 and Day 7 after kidney transplantation.

NCT ID: NCT03016455 Recruiting - Renal Transplant Clinical Trials

B Cell Lymphocyte in Humoral Rejection and Alloimmunisation

BHL
Start date: June 2013
Phase: N/A
Study type: Observational

This study aims to better characterise B cell phenotype and functional abnormalities in kidney transplant patients producing donor specific antibody (DSA) and in those with chronic antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). The functional analysis will help to better understand B cell-dependant mechanisms implied in T cell proliferation and better target future treatments.

NCT ID: NCT02951442 Completed - Renal Transplant Clinical Trials

Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant

KLOTHO
Start date: January 2011
Phase: N/A
Study type: Interventional

The primary objective is to show that the contribution of Klotho by the renal graft is an independent determinant of the evolution of the recipient's central arterial stiffness during the first year of renal transplant. The contribution of Klotho by the graft will be estimated by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by the circulating concentrations of FGF23. The recipient's central arterial stiffness will be estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference method for measuring aortic stiffness in human.

NCT ID: NCT02894606 Recruiting - Renal Transplant Clinical Trials

Influence of Thymoglobuline on Phenotypic and Functional Profiles of B Lymphocytes in Renal Transplant Recipients

THYMO B
Start date: February 2015
Phase: N/A
Study type: Observational

The investigators expect to better characterise B cell subpopulation and functional properties early after graft, to analyse effect of induction therapy (thymoglobulin versus basiliximab) on B cells, and to compare this B cell profiles with those obtained in our previous study in patients with chronic Antibody Mediated Rejection (cAMR)

NCT ID: NCT02738918 Completed - Renal Transplant Clinical Trials

Belatacept (Nulojix) in Renal Transplant Recipient With Mild Immunologic Risk Factor: a Pilot Prospective Study.

BELACOR
Start date: December 1, 2014
Phase: Phase 2
Study type: Interventional

BACKGROUND: Antibody-mediated humoral rejection is currently a critical question in renal transplant recipient with immunological risk factors such as pre transplant donor-specific anti HLA antibodies (DSA). The immunosuppressive management of the patients is still not well defined and improving both short and long-term graft outcome remains a challenging question. Recent experimental data suggest that Belatacept could induce B cell anergy , induce regulatory B cell and decrease Ig production. These findings are strengthened by the results of both phase II and III clinical studies, showing a significant lower incidence of DSA in patients treated with Belatacept compared to recipients receiving a conventional immunosuppressive regimen with calcineurin inhibitors (CNI). Primary objective will be the incidence of clinical and subclinical humoral rejection (According to BANFF 2011 Criteria). Secondary objectives will include one-year graft and patient survival, renal function at M12 (MDRD), incidence of cellular rejection (M 12), level of proteinuria (M3 and M12) and DSA outcome (outcome of DSA MFI at JO, M3 and M12). Inclusion period will be of two years. DSA identification and quantitative analysis before and after transplantation will be centralized in only one HLA laboratory Unit (Hospital Saint Louis) for providing results homogeneity. According to previous clinical studies, the incidence of Acute Antibody Mediated Humoral Rejection is close to 20% in patients with mild immunological risk defined by the presence of DSA at the time of transplant with mean fluorescence intensity (MFI) between 1000 and 3000 (Luminex). In order to demonstrate a significant reduction (40%) of AAMR and sAAMR incidence, 91 patients will be included in this study. Results will be compared to a cohort matched for age, sex, immunological risk factor (DSA), time of transplant, transplant center and grafted with a similar immunosuppressive regimen including CNI instead of Belatacept

NCT ID: NCT02711826 Completed - Kidney Transplant Clinical Trials

Treg Therapy in Subclinical Inflammation in Kidney Transplantation

TASK
Start date: September 20, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is: - To see if polyTregs can reduce inflammation in a transplanted kidney. - To find out what effects, good or bad, polyTregs will have in the kidney recipient. - To find out what effects, good or bad, taking everolimus after polyTregs will have in the kidney recipient.

NCT ID: NCT02581644 Completed - Renal Transplant Clinical Trials

Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries

Start date: November 29, 2016
Phase: N/A
Study type: Observational

The purpose of the study is to determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

NCT ID: NCT02412345 Completed - Clinical trials for Erectile Dysfunction

Extracorporeal Shockwave Therapy in the Treatment for Erectile Dysfunction in Male Renal Transplant Recipients

Start date: January 2015
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine the impact of the shock wave application in renal transplant patients with diagnosis of erectile dysfunction. Secondary objectives are to assess the effects of therapy on quality of life and depression. It is expected that with the study is defined the usefulness of the therapy and the dissemination of knowledge generated for change in clinical management in renal transplant patients with erectile dysfunction.

NCT ID: NCT02117596 Completed - Renal Transplant Clinical Trials

Calcineurin Inhibitor Based Immunosuppression Withdrawal

CNI-W
Start date: November 2007
Phase: N/A
Study type: Interventional

Damage and scarring of a transplanted kidney has become the most common cause of loss of the transplanted kidney. This kidney damage is a complex process caused by many factors including injury during obtaining and transplanting the kidney, injury from the immune system, injury from infections, and injury from drugs used to stop rejection. This injury leads to scars that decrease the kidney's ability to function properly, and over time the kidney is lost. Prograf® (tacrolimus) has been one of the main drugs used to prevent rejection. However, when used over time it has been shown to cause chronic damage and scarring in the transplanted kidney. The purpose of this experimental study is to determine whether children can safely be withdrawn from Prograf® after transplantation and changed to Rapamycin® (sirolimus). Recent research studies in adult transplantation have demonstrated that with the use of Rapamycin® (sirolimus), it is possible to discontinue the use of Prograf (tacrolimus) with no increase in rejection, with decreased scarring in the kidney, and with improvements in kidney function and survival of the kidney. A total of 50 children will enroll in this study at university centers around the country. This study will last about 3 years.

NCT ID: NCT02049827 Completed - Renal Transplant Clinical Trials

Evaluation of a Predictive Immunovirological Test Occurrence of BK Virus Nephropathy in Renal Transplant

Start date: February 19, 2014
Phase: N/A
Study type: Interventional

Kidney transplantation is the treatment of choice for end stage renal disease (ESRD) improving the quantity and quality of life for dialysis patients. Although prolongation of graft survival in the short term by preventing the release is observed by immunosuppression (IS) powerful, the longer-term survival has not improved . Indeed, the IS can not only have a direct deleterious effect on the kidney transplant , but too weak IS can promote rejection, and too strong, promote the emergence of a viral disease polyomavirus BK ( BKV ) . BK nephropathy (BKVAN ) virus is accompanied by an irreversible impairment of the renal function , leading to a loss of the graft followed by a premature return to dialysis in at least 50 % of cases. Plasma BKV reactivation was observed mainly during the first year of transplantation in 15% of patients and complications annually BKVAN concern about 5 % of recipients . Currently , treatment options are very limited , only the decrease in IS shows a partially effective when care is early . There is no specific antiviral effective treatment of this disease . In addition, there is no way to predict which patients will develop BKV reactivation BKVAN despite lower tax. The diagnosis of interstitial nephritis BKV based on the detection of viral DNA by PCR and plasma is confirmed by histological analysis of renal tissue . Plasma quantitative PCR ( qPCR) to measure the progression of the disease and therapeutic efficacy. Control of BKV viremia is the direct antiviral immune response quality based primarily on a very effective anti- T lymphocyte activity BKV reflection. In this context, the inhibition of lymphocyte activation induced by IS blocks the establishment of T-cell responses anti- BKV in most transplant, a very low presence of T lymphocytes is generally observed in these patients anti- BKV (LYT - BKV) blood . Our preliminary studies have validated in vitro a sensitive test to measure the functionality of blood LYT - BKV. This test is used to evaluate the concentration and functionality of LYT - BKV present in small volume of blood by measuring their specific proliferation after stimulation with peptide cocktails BKV. Proof of concept of the feasibility of this test was established on a small series of samples and highlights significant differences in lymphocyte anti-BKV different patients. Put to good use during the post-transplant follow-up, this type of test can provide the clinician with valuable data to assess the quality of anti- BKV T response compared to the intensity and type of IS treatment. Early identification of patients at risk of reactivation of BKV, or at risk of BKVAN if BKV viremia observed , would adapt the therapeutic response and monitoring arrangements at the fair. The objective of this project is to conduct a feasibility study to assess the relevance of post-transplant monitoring of anti- BKV T response of BKV viremic patients during the first year post- transplant. Immunological data will be analyzed in relation to virological data and bioclinical data.